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EC number: 224-923-5 | CAS number: 4553-62-2
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Reverse gene mutation assay:
One study was available and considered as the key study (Zeiger, 1988).
In a reverse gene mutation assay in bacteria performed similarly to the OECD test guideline No. 471, strains TA 1535, TA 1537, TA 97, TA 98 and TA 100 of S. typhimuriumwere exposed to methylglutaronitrile (85%) in DMSO at concentrations of 0; 100; 333; 1000; 3333 and 10000 µg/plate. Tests were conducted in the presence and absence of mammalian metabolic activation (S-9 fractions of Aroclor 1254-induced males Sprague-Dawley rat and male Syrian hamsters livers (5, 10 or 30 %)).
The positive controls induced the appropriate responses in the corresponding strains.
For the TA100, TA1535, TA1537 and TA98, the results are clearly negative with and without metabolic activation.
For the TA97 strain, the author judged the results as ambigous. However, the number of revertants with the test item for the TA 97 strain with and without metabolic activation did never exceed twice the number of revertants obtained with the vehicule control. Therefore, when the number of revertants with the test item increased, this increase can not be considered as significant (expert judgement). Under the test conditions, Methylglutaronitrile is not mutagenic in bacteria.
In vivo genotoxicity:
No key study was identified. In a Swiss CFLP mouse bone marrow micronucleus assay (Siou, 1981), 10 males/dose were treated by oral gavage with 2- methylglutaronitrile (purity unknown) at doses of 2 x 0.01 and 2 x 0.05 mL/kg bw. Bone marrow cells were harvested at 6 hours post-treatment.
In this study, only the percentage of micronuclei in polychromatic erythrocytes is determined and no effects were seen after treatment. However, there is no information concerning proportion of immature erythrocytes among total erythrocytes and the accessibility of the product to the bone marrow. The cytotoxicity of the product is missing. There are several other deviations. Therefore no conclusion can be established based on this study (Kr:3).
Short description of key information:
Bacterial reverse gene mutation assay/Ames test: negative in S. typhimurium TA 1535, TA 1537, TA 97, TA 98 and TA 100 at concentrations of 0,
100, 333, 1000, 3333 and 10000 µg/plate
Endpoint Conclusion:
Justification for classification or non-classification
2 -Methylglutaronitrile is not mutagenic in bacteria but no proposal for genotoxicity classification is possible because data available are not sufficient.
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